LYON, France — September 18, 2026

MaaT Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) maintained its negative opinion on the company’s application for Conditional Marketing Authorization for MaaT013 (Xervyteg®) following re-examination. The investigational microbiome therapy is being developed for adult patients with gastrointestinal involvement from acute graft-versus-host disease (aGvHD) who are refractory to prior lines of therapy. The CHMP concluded that the existing clinical evidence, based primarily on a single-arm trial, was insufficient to adequately characterize the product’s benefit-risk profile.

PHOENIX Phase 3 Trial Designed to Address Evidence Requirements

MaaT Pharma plans to advance PHOENIX, a randomized, controlled, open-label Phase 3 trial evaluating MaaT013 against Best Available Therapy (BAT) in patients with corticosteroid- and ruxolitinib-refractory aGvHD. The global study is expected to enroll approximately 138 patients in a 1:1 randomization and will use Day 28 all-organ Overall Response Rate as its primary endpoint, alongside secondary efficacy and safety measures. MaaT Pharma proposed PHOENIX during the European regulatory process as a potential source of the additional randomized evidence needed to further characterize MaaT013’s benefit-risk profile.

FDA Feedback Supports Registrational Development Strategy

Feedback from a Type C interaction with the U.S. Food and Drug Administration supports advancement of PHOENIX as a pivotal Phase 3 registrational study, according to MaaT Pharma. The company is progressing clinical readiness activities, including feasibility assessments across major clinical trial sites in the United States and other planned countries. Subject to regulatory clearance and appropriate financing, the study could begin with potential first-patient enrollment in the first half of 2027 and is planned to include sites in the U.S., Europe and other regions. MaaT Pharma said the study could support future regulatory submissions across multiple territories if successfully executed and supported by positive results.

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MaaT Pharma Extends Cash Horizon While Reviewing Assets

MaaT Pharma is conducting a strategic review of its assets while implementing additional cash-preservation measures, extending its projected cash horizon to December 2026 from November 2026 based on current operating assumptions. The company is also exploring a U.S.-focused development pathway for MaaT013 with the objective of supporting potential global registration. MaaT013 is an off-the-shelf, standardized, pooled-donor Microbiome Ecosystem Therapy™ administered as an enema and designed to restore gut microbiome balance and modulate immune function. The candidate has received Orphan Drug Designation from both the FDA and EMA, but remains investigational and has not received marketing authorization.

Source:MaaT Pharma, press release